I had no idea I was a criminal lawyer...

Author: Alexander Stack Professional Corporation |

Anyone know any good criminal law associations to join? I've apparently been practicing criminal law for the past few years without knowing it ;)

OK, putting jokes aside, before Christmas the Federal Court of Appeal in Apotex v. Eli Lilly found that the Data Protection Regulations are valid federal legislation. What raised a lot of eyebrows is that the regulations were found to be valid federal legislation under the criminal law power. The trial judge, in contrast, found it was valid under the trade and commerce clause.

The FCA decision in a nutshell

[117] I therefore conclude that the pith and substance of the [Data Protection Regulations] is to implement article 1711 of NAFTA and paragraph 3 of article 39 of TRIPS so as to encourage the development of new drugs, a valid public health and safety purpose.

[118] I now turn to the question of whether the pith and substance of the [Data Protection Regulations] falls within federal legislative authority under the Constitution Act. In my view, the [Data Protection Regulations] constitutes a valid exercise of the federal criminal law power under subsection 91(27) of the Constitution Act.

In short, and not doing the analysis real justice, the regulations as a whole are about allowing and encouraging safe and effective drugs to be placed on the market on pain of criminal sanctions. (Background - if you sell a medicine in Canada without a Notice of Compliance from Health Canada, it is a criminal act)

The FCA quoted the Supreme Court in RJR-MacDonald:

The scope of the federal power to create criminal legislation with respect to health matters is broad, and is circumscribed only by the requirements that the legislation must contain a prohibition accompanied by a penal sanction and must be directed at a legitimate public health evil.

The counterargument is that the Data Protection Regulations themselves are about protecting expensive-to-gather data to encourage its generation. In the words of the trial judge:

[79] I conclude that the pith and substance of the Data Protection Regulation is the balancing of commercial considerations between the protection of an innovator drug manufacturer’s investments in preparing the NDS information in order to obtain an NOC for a new drug and the eventual NOC approval of generic drug manufacturer’s ANDS for a lower cost generic version of the new drug.

One can then argue about whether that pith and substance falls under a head of federal power.

Anyway, I am not a constitutional lawyer (although if someone paid me, I could probably figure it out pretty quick ;) ). However, as Andrew Moeser pointed out, the Supreme Court of Canada about two weeks later released Reference re Assisted Human Reproduction Act, which held that the Act was not a valid exercise of the criminal law power and intruded on provincial jurisdiction - albeit the court badly fractured on the issue. As Andrew pointed out (not having read the case in detail) the AHR Act deals with human reproductive material and engaging in human/non-human transgenic engineering without a license - and that is not a valid exercise of the criminal law power, but data exclusivity is?

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